Protocol summary

Study aim
investigate the effect of Date Palm Pollen on liver enzymes and ovarian volume in women with PCO
Design
This double-blind randomized controlled clinical trial study is conducted in parallel, on patients referred to women's educational clinics in Abadan and Khorramshahr cities. The sample size is considered to be 40 people based on previous studies.
Settings and conduct
training clinics in Abadan and Khorramshahr cities
Participants/Inclusion and exclusion criteria
Women with polycystic ovary syndrome are eligible; People who use tobacco and alcohol or suffer from chronic kidney, liver, lung diseases and chronic or acute inflammatory diseases (especially acute inflammation of the pancreas), thyroid dysfunction, heart valve disease, short bowel syndrome Also, people with low immune system ability (autoimmunity) are removed from the list of eligible people (this condition is approved by the clinical consultant for the studied people), as well as people who are allergic to medicine or placebo during the study and or take chemotherapy drugs (tamoxifen) and corticosteroids, or drugs that affect blood sugar and lipids (insulin injection, statins, diuretics), antibiotics and vitamin supplements and omega-3, or have one of the diseases If the above-mentioned patients were hospitalized or had to change the dosage of the drugs they were taking, they were excluded from the study.
Intervention groups
In this study, people will be divided into two control and intervention groups using a random number table. The first group will be under the standard drug regimen (metformin + spironolactone) for the treatment of PCO along with the daily intake of 400 mg of date palm pollen, and the second group will be under the standard medication regimen for the treatment of PCO along with the daily intake of 400 mg of the placebo drug (dry bread).
Main outcome variables
Evaluation of biomarkers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230531058351N1
Registration date: 2023-06-21, 1402/03/31
Registration timing: prospective

Last update: 2023-06-21, 1402/03/31
Update count: 0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
samaneh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
samaneh_k_500@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-22, 1402/06/31
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Date Palm Pollen on follicogenesis and liver enzymes in women with polycystic ovary syndrome: a double-blind randomized clinical trial
Public title
Investigating the effect of Date Palm Pollen on women with polycystic ovary syndrome
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
To diagnose polycystic ovary syndrome according to the Rotterdam criteria, two of the following must be present: 1- Amenorrhea or reduced ovulation frequency Presence of hyperandrogenism based on clinical symptoms (hirsutism and male pattern hair loss) or laboratory (androgen increase) free or increased free androgen index) the presence of evidence of polycystic ovary in ultrasound.
Exclusion criteria:
People who use tobacco and alcohol. People suffering from chronic kidney, liver, lung diseases and chronic or acute inflammatory diseases (especially acute inflammation of the pancreas), thyroid dysfunction, heart valve disease, short bowel syndrome. Also, people with low ability of immune system (autoimmunity) are removed from the list of eligible people. These conditions are approved by the clinical consultant in the case of the studied subjects. Also, people who are allergic to medicine or placebo during the study. or taking chemotherapy drugs (tamoxifen) and corticosteroids, or drugs affecting blood sugar and lipids (insulin injections, statins, diuretics), antibiotics and vitamin supplements and omega 3, or suffering from one of the above-mentioned diseases Either they were admitted to the hospital or they had to change the dosage of the drugs they were taking, they were excluded from the study. To overcome the confounding factors, we use the general information questionnaire and the three-day record of people's food intake.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: table of random numbers In this study, 80 envelopes will be designed, in which there is code A or code B inside each envelope. These codes will indicate the allocation or non-allocation of the intervention. In advance, the necessary coordination will be made with the pharmaceutical company to make the drug and placebo, and the drug and placebo will be separated in containers with code A and B. According to the double-blind study, neither the doctor nor the patient will be unaware of these containers. The patient goes to the doctor and the doctor will place the person in one of these two groups with the help of a table of random numbers. This will continue until 80 people are placed in two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people will be divided into two control and intervention groups using a random number table. . Date palm pollen and dry bread powder will be packaged and coded in exactly the same packages, and the researcher and the subject are not aware of the type of supplement consumed in the packages.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committees of Abadan School of Medical Sciences
Street address
Zulfiqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Approval date
2022-09-13, 1401/06/22
Ethics committee reference number
IR.ABADANUMS.REC.1401.068

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Alanine Aminotransferase(ALT)
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week
Method of measurement
VT3000 device will be used to measure liver enzymes.

2

Description
Aspartate Aminotransferase(AST)
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week
Method of measurement
VT3000 device will be used to measure liver enzymes.

3

Description
Alkaline Phosphatase(ALK-P)
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
VT3000 device will be used to measure liver enzymes.

4

Description
17α hydroxy-progesterone
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
LC/MS/MS device is used to measure steroid hormones.

5

Description
Progesterone
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
LC/MS/MS device is used to measure steroid hormones.

6

Description
androstenedione
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
LC/MS/MS device is used to measure steroid hormones.

7

Description
estrogen
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
LC/MS/MS device is used to measure steroid hormones.

8

Description
LH
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
LC/MS/MS device is used to measure steroid hormones.

9

Description
CBC
Timepoint
Measurement of biomarkers at the beginning of the study and after the twelfth week.
Method of measurement
Blood tests are performed by means of TB counter machines.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: participants in the intervention group received 400 mg Date Palm Pollen once a day after lunch for 12 weeks. After characterizing Date Palm Pollen native to Abadan city, Karen Pharmaceutical Company prepares the product in the form of capsules, Pearl 400 mg. The subjects and the researcher do not know about the allocation of groups. In order to hide the assignment of people to groups, sealed envelopes are used (containing the identification group code of each person along with inserting the person's number on the envelope). A time table is designed to take the medicine. Drug intake was assessed by counting the remaining pearls and by excluding participants who did not consume more than 30% of the drug.
Category
Treatment - Drugs

2

Description
Control group: Participants in the control group received placebo Pearl (dry bread) 400 mg once a day after lunch for 12 weeks. In terms of appearance, placebos are completely similar to date palm pollen herbal medicine, both of which are produced by Karen Pharmaceuticals and Vital Food Supplements Company (Yazd-Tehran). The investigated people and the researcher do not know about the allocation of groups. Placebo and date palm pollen herbal medicine are coded by the manufacturing company. In order to hide the assignment of people to groups, sealed envelopes are used (containing the assigned group code of each person along with the individual's number on the envelope). A schedule is designed to remind you to take the medicine. The evaluation of drug consumption is done by counting the remaining pearls and by removing the participants who have not consumed more than 30% of the drug.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Women's educational clinics in Abadan and Khorramshahr cities
Full name of responsible person
Samaneh Karimi
Street address
Zulfiqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5326 7800
Email
samaneh_k_500@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Educational and Research Vice-Chancellor of Abadan University of Medical Sciences
Full name of responsible person
Nabi Jome zadeh
Street address
Zulfiqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5326 7800
Email
samaneh_k_500@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Educational and Research Vice-Chancellor of Abadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Samaneh Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Zulfiqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5326 7800
Email
samaneh_k_500@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Samaneh Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Zulfiqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5326 7800
Email
samaneh_k_500@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Samaneh Karimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Zolfaqari St, Abadan University of Medical Sciences
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5326 7800
Email
samaneh_k_500@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Published as an article
When the data will become available and for how long
After publication as an article
To whom data/document is available
After publication as an article
Under which criteria data/document could be used
Published as an article
From where data/document is obtainable
Author
What processes are involved for a request to access data/document
Published as an article
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